UNCPM 22314 - Pregnancy, Infant and Maternal Health Outcomes Study

Summary

The primary purpose of this study is to assess the safety of long-acting injectable cabotegravir (CAB-LA) and oral pre-expose prophylaxis (PrEP) (FTC/TDF or 3TC/TDF) for the prevention of HIV during pregnancy and breastfeeding among pregnant women and their infants in Malawi. The main question the study aims to answer is: \- Do composite adverse pregnancy events, maternal health outcomes, and/or infant health outcomes differ between individuals taking oral PrEP and those taking CAB-LA? Women who are already using PrEP at the time of pregnancy diagnosis or those who initiate PrEP during pregnancy will enroll into a Safety Cohort where they will be closely followed up during pregnancy while optimizing their antenatal care (ANC) per the Malawi ANC package. Women will have access to either CAB-LA or oral PrEP and will be given an opportunity to choose one option. Women and their infants will attend a series of follow-up visits through pregnancy, birth, and the postnatal period. In addition, the study will contribute to the development of a national PrEP Pregnancy Registry which will be initially rolled out in Lilongwe and Blantyre -the two most populous cities in Malawi-before a nationwide roll out begins under the guidance of the Malawi Ministry of Health.

Timeline

Start

2024-04-17

Primary completion

2026-12

Completion

2027-12

Publications

• Kamanga F, Squibb MA, Nyangulu W, Wu W, Chen J, Ngwira C, Drabko A, Garbarek W, Pomykala M, Bilicki D, Nakanga C, Masiye G, Chinula L, Mvalo T, Chagomerana MB, Matoga MM, Kumwenda W, Mkochi T, Matola E, Dias P, Mkochi N, Thonyiwa V, Nyirenda RK, Chewere L, Ozituosauka W, Jahn A, Nkhonjera J, Odek J, Hoege D, Schwartz S, Chauwa F, Dadabhai S, Phiri S, Rutstein SE, Herce M, Hoffman I, Allinder S, Holmes CB, Hosseinipour MC, Saidi F. Developing a surveillance system for HIV pre-exposure prophylaxis (PrEP) use in pregnancy in Malawi. BMC Pregnancy Childbirth. 2026 May 8;26(1):695. doi: 10.1186/s12884-026-09190-2.
• Saidi F, Shah S, Squibb M, Chinula L, Nakanga C, Mvalo T, Matoga M, Bula AK, Chagomerana MB, Kamanga F, Kumwenda W, Mkochi T, Masiye G, Moya I, Herce ME, Rutstein SE, Thonyiwa V, Nyirenda RK, Mwapasa V, Hoffman I, Hosseinipour MC. Evaluating the impact of HIV pre-exposure prophylaxis on pregnancy, infant, and maternal health outcomes in Malawi: PrIMO study protocol. BMC Public Health. 2024 Sep 27;24(1):2604. doi: 10.1186/s12889-024-20029-3.

Drugs

Indications